Development of a simple method for predicting the levels of di(2-ethylhexyl) phthalate migrated from PVC medical devices into pharmaceutical solutions

International Journal of Pharmaceutics

Volumn 298, Issue 1, 2005, Pages 126-142

  Haishima, Yuji ^a   Seshimo, Fumie ^b   Higuchi, Tae ^b   Yamazaki, Haruko ^b   Hasegawa, Chie ^a   Izumi, Shun Ichiro ^c   Makino, Tsunehisa ^c   Nakahashi, Keisuke ^d   Ito, Rie ^b   Inoue, Koichi ^b   Yoshimura, Yoshihiro ^b   Saito, Koichi ^b   Yagami, Takeshi ^a   Tsuchiya, Toshie ^a   Nakazawa, Hiroyuki ^b  

^a NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

^b HOSHI UNIVERSITY   (Japan)

^c TOKAI UNIVERSITY   (Japan)

^d TERUMO CORPORATION   (Japan)

Author keywords

DEHP; Medical device; Prediction; PVC; Risk assessment

Indexed keywords

4 DIMETHYLAMINOAZOBENZENE; 4 OXYMETHYLBENZOATE; 4 OXYPROPYLBENZOATE; ACETIC ACID; ACTIT; ADRENALIN; ALCOHOL; AMINO ACID DERIVATIVE; AMINOETHYLSULFONIC ACID; AMPICILLIN; ANTHRAQUINONE DERIVATIVE; ANTITHROMBIN III; ASPARTIC ACID; ASPOXICILLIN; ATONIN; ATROPINE; BENZOIC ACID; BENZYL ALCOHOL; BICARBONATE; BISULFITE; BROMHEXINE; CALCICOL; CARBAZOCHROME; CARBAZOCHROME SODIUM SULFONATE; CEFAMIZINE; CEFAZOLIN; CEFTAZIDIME; CHLORBUTOL; CILASTATIN PLUS IMIPENEM; CITRATE SODIUM; CLINDAMYCIN; CYCLOSPORIN A; CYSTEINE; DEXPANTHENOL; DIAZEPAM; DIPROPHYLLINE; DIPYRONE; DODECYL SULFATE SODIUM; DOYLE; DROPERIDOL; DRUG ADDITIVE; EDETATE SODIUM; ELECTROLYTE; ERYTHROMYCIN; ETHYLENEDIAMINE; FAMOTIDINE; FLUCONAZOLE; FLURBIPROFEN AXETIL; FOSFOMYCIN SODIUM; FOSMISIN; GLUCONATE CALCIUM; GLUCOSE; GLYCEROL; GLYCERYL TRINITRATE; GLYCOLIC ACID DERIVATIVE; HALOPERIDOL; HUMAN ALBUMIN; HUMAN INSULIN; HYDROCHLORIC ACID; HYDROXYZINE; IMMUNOGLOBULIN G; INSULIN; IOVERSOL; IRON SACCHARATE; ISOPRENALINE; KENKETSU VENOGLOBIN; LACTIC ACID; MAGNESIUM CHLORIDE; MALTOSE; MANNITOL; MENATETRENONE; META CRESOL; METHOTREXATE; METHYLERGOMETRINE MALEATE; MICONAZOLE NITRATE; MINOCYCLINE; MUSCULAX; NICARDIPINE; OCTANOIC ACID; OIL SCARLET; OXYTOCIN; PANIPENEM PLUS BETAMIPRON; PARTAN M; PEROXYDISULFATE POTASSIUM; PHENOL; PHENYTOIN; PHOSPHATIDYLCHOLINE; PHTHALIC ACID BIS(2 ETHYLHEXYL) ESTER; PIGMENT; PN TWIN; POLYSORBATE 20; POLYSORBATE 80; POLYVINYLCHLORIDE; POTASSIUM CHLORIDE; PREDNISOLONE; PREDNISOLONE SODIUM SUCCINATE; PROPOFOL; PROPYLENE GLYCOL; PROSTAGLANDIN F2 ALPHA; PROSTARMON; RANITIDINE; RICINOMACROGOL; ROPION; SESAME SEED OIL; SIVELESTAT; SODIUM CARBONATE; SODIUM CHLORIDE; SODIUM DIHYDROGEN PHOSPHATE; SODIUM HYDROXIDE; SODIUM METABISULFITE; SODIUM N ACETYLTRYPTOPHAN; SODIUM THIOGLYCOLLATE; SOHVITA; SORBITOL; SOYBEAN OIL; SUCCIN; SURFACTANT; SUXAMETHONIUM; TACROLIMUS; UNCLASSIFIED DRUG; VECURONIUM; VITAMIN;

ARTICLE; COMPARATIVE STUDY; CONCENTRATION RESPONSE; CONTACT ANGLE; CORRELATION ANALYSIS; DRUG CONTAMINATION; ELECTRIC CONDUCTIVITY; ELUTION; EXTRACTION; GAS CHROMATOGRAPHY; HORIZON; LIPOPHILICITY; MASS SPECTROMETRY; MEDICAL INSTRUMENTATION; OPTICAL DENSITY; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; SOLUBILITY;

DIETHYLHEXYL PHTHALATE; DRUG CONTAMINATION; EQUIPMENT AND SUPPLIES; GAS CHROMATOGRAPHY-MASS SPECTROMETRY; INJECTIONS; POLYVINYL CHLORIDE; RISK ASSESSMENT; SOLUBILITY; SOLUTIONS;

EID: 20444494849     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2005.04.009     Document Type: Article

References (29)

1. M.C. Allwod The release of phthalate ester plasticizer from intravenous administration sets into fat emulsion Int. J. Pharm. 29 1986 233 236
2. H. Atkinson, and S.B. Duffull Prediction of drug loss from PVC infusion bags J. Pharm. Pharmacol. 43 1991 374 376
3. Center for Devices and Radiological Health, U.S. Food and Drug Administration, 2001. Safety assessment of di(2-ethylhexyl)phthalate (DEHP) released from PVC medical devices. Web site at http://www.fda.gov/cdrh/nespg. html.
4. B.J. Davis, R.R. Maronpot, and J.J. Heindel Di-(2-ethylhexyl)phthalate suppressed estradiol and ovulation in cycling rats Toxicol. Appl. Pharmacol. 128 1994 216 223
5. Y. Haishima, Y. Hayashi, T. Yagami, and A. Nakamura Elution of bisphenol-A from hemodialyzers consisting of polycarbonate and polysulfone resins J. Biomed. Mater. Res. Part B: Appl. Biomater. 58 2001 209 215
6. Y. Haishima, R. Matsuda, Y. Hayashi, C. Hasegawa, T. Yagami, and T. Tsuchiya Risk assessment of di(2-ethylhexyl)phthalate released from PVC blood circuits during hemodialysis and pump-oxygenation therapy Int. J. Pharm. 274 2004 119 129
7. T. Hanawa, E. Muramatsu, K. Asakawa, M. Suzuki, M. Tanaka, K. Kawano, T. Seki, K. Juni, and S. Nakajima Investigation of the release behavior of diethylhexyl phthalate from the polyvinyl-chloride tubing for intravenous administration Int. J. Pharm. 210 2000 109 115
8. T. Hanawa, N. Endoh, F. Kazuno, M. Suzuki, D. Kobayashi, M. Tanaka, K. Kawano, Y. Morimoto, S. Nakajima, and T. Oguchi Investigation of the release behavior of diethylhexyl phthalate from polyvinyl chloride tubing for intravenous administration based on HCO60 Int. J. Pharm. 267 2003 141 149
9. Y. Hayashi, and R. Matsuda Deductive prediction of measurement precision from signal and noise in liquid chromatography Anal. Chem. 66 1994 2874 2881
10. Y. Hayashi, R. Matsuda, and R.B. Poe Probabilistic approach to confidence intervals of linear calibration Analyst 121 1996 591 599
11. Y. Hayashi, R. Matsuda, Y. Haishima, T. Yagami, and A. Nakamura Validation of HPLC and GC-MS systems for bisphenol-A leached from hemodialyzers on the basis of FUMI theory J. Pharm. Biomed. Anal. 28 2002 421 429
12. D.S. Hayward, R.A. Kenley, and D.R. Jenke Interactions between polymer containers and parenteral solutions: the correlation of equilibrium constants for polymer-water partitioning with octanol-water partition coefficients Int. J. Pharm. 59 1990 245 253
13. Health Canada, 2002. Expert Advisory Panel on DEHP in Medical Devices. Web site at http://www.hc-sc.gc.ca/hpb-dgps/therapeut/hemleng/whatsnew.html.
14. K. Inoue, M. Kawaguchi, F. Okada, Y. Yoshimura, and H. Nakazawa Column-switching high-performance liquid chromatography electrospray mass spectrometry coupled with on-line of extraction for the determination of mono- and di-(2-ethylhexyl) phthalate in blood samples Anal. Bioanal. Chem. 375 2003 527 533
15. K. Inoue, T. Higuchi, F. Okada, H. Iguchi, Y. Yoshimura, A. Sato, and H. Nakazawa The validation of column-switching LC/MS as a high-throughput approach for direct analysis of di(2-ethylhexyl)phthalate released from PVC medical devices in intravenous solution J. Pharm. Biomed. Anal. 31 2003 1145 1152
16. D.R. Jenke Effect of solution phase composition on the interaction between aqueous model solutes and polymeric container materials Pharm. Res. 8 1991 782 786
17. D.R. Jenke Evaluation of model solvent systems for assessing the accumulation of container or extractables in drug formulations Int. J. Pharm. 224 2001 51 60
18. D.R. Jenke, R.A. Kenley, and D.S. Hayward Interactions between polymeric containers and their contained solution: modeling of polymer-water solute partitioning via coupled solvent-water partition coefficients J. Appl. Polym. Sci. 43 1991 1475 1482
19. D.R. Jenke, E.K. Chess, D.C. Zietlow, and B.E. Rabinow Model for estimating the accumulation of solutes leaching from polymeric containers into parenteral solutions Int. J. Pharm. 78 1992 115 122
20. R.A. Kenley, and D.R. Jenke Determination of solute-polymer interaction properties and their application to parenteral product container compatibility evaluations Pharm. Res. 7 1990 911 918
21. J.C. Lamb, R.E. Chapin, J. Teague, A.D. Lawton, and J.R. Reel Reproductive effects of four phthalic acid esters in the mouse Toxicol. Appl. Pharmacol. 88 1987 255 269
22. S. Loff, F. Kabs, K. Witt, J. Sartoris, B. Mandl, K.H. Niessen, and K.L. Waag Polyvinylchloride infusion lines expose infants to large amounts of toxic plasticizers J. Pediatr. Surg. 35 2000 1775 1781
23. K. Nasim, M.C. Meyer, and J. Autin Permeation of aromatic organic compounds from aqueous solutions through polyethylene J. Pharm. Sci. 61 1972 1775 1780
24. G.C. Pitt, Y.T. Bao, A.L. Andrady, and P.N.K. Samuel The correlation of polymer-water and actanol-water partition coefficients: estimation of drug solubility in polymers Int. J. Pharm. 45 1988 1 11
25. R. Poon, P. Lecavalier, R. Mueller, V.E. Valli, B.G. Procter, and I. Chu Subchronic oral toxicity of di-n-octyl phthalate and di(2-ethylhexyl)phthalate in the rat Food Chem. Toxicol. 35 1997 225 239
26. M.S. Roberts, E.A. Kowaluk, and A.E. Polack Prediction of solute sorption by polyvinyl chloride plastic infusion bags J. Pharm. Sci. 80 1991 449 455
27. S. Takatori, Y. Kitagawa, M. Kitagawa, H. Nakazawa, and S. Hori Determination of di(2-ethylhexyl)phthalate in human serum using liquid chromatography-tandem mass spectrometry J. Chromatogr. B 804 2004 397 401
28. J.A. Tickner, T. Schettler, T. Guidotti, M. McCally, and M. Rossi Health risks posed by use of di-2-ethylhexyl phthalate (DEHP) in PVC medical devices: a critical review Am. J. Ind. Med. 39 2001 100 111
29. R.W. Tyl, C.J. Price, M.C. Marr, and C.A. Kimmel Developmental toxicity evaluation of dietary di(2-ethylhexyl)phthalate in Fischer 344 rats and CD-1 mice Fundam. Appl. Toxicol. 10 1988 395 412